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TAN SIN LIAN INDUSTRIES SDN BHD

www.tansinlian.com

✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, United Kingdom, Brazil, Saudi Arabia, Australia, Russia — 6 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

0UDI-DI device records

USUnited StatesFDA openFDA

1listed device types

Class I 1Class II 0Class III 0

plus 2 registration records and 2 510(k)

UKUnited KingdomMHRA PARD

3registered device records

Class I 3

BRBrazilANVISA

3registered devices

Class I 3

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

5registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

0active device licences

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

3active ARTG entries

Class I 3

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

2active registrations

Class 2a 2

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

European Union30,747 raw hits, 100 excluded, 0 confirmed. Large result set — only the first 300 verified

United States2 registration records, 2 510(k), 0 PMA, 3 excluded

United Kingdom3 confirmed, 49 excluded

Brazil3 confirmed, 0 excluded

Saudi Arabia5 confirmed, 0 excluded

Manufacturer names merged into this page: TAN SIN LIAN INDUSTRIES SDN. BHD. · TAN SIN LIAN INDUSTRIES SDN BHD · Tan Sin Lian Industries Sdn Bhd · Tan Sin Lian Industries Sdn. Bhd

Regulatory identity

UK responsible person: Obelis UK Ltd
Exhibition record: CMEF 89th (Apr 2024, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

Registration details (sample)

Market	Identifier	Name	Class / date
UK	47172	Qualatex Powder Free Latex Examination Gloves	Class I
UK	47173	Qualatex Powdered Latex Examination Gloves	Class I
UK	56286	Qualatex Powder Free Nitrile Examination Gloves	Class I
US	K031335	POWDER FREE LATEX EXAM GLOVES	2003-10-16
US	K992557	QUALATEX POWDERED LATEX EXAMINATION GLOVES	1999-09-14
BR	10341520018	Luva de Procedimento Não Estéril Powder Free	Class I
BR	10341520019	Luva de Procedimento Não Estéril	Class I
BR	82355750001	LUVAS PARA PROCEDIMENTOS NÃO CIRÚRGICOS DE LÁTEX COM PÓ	Class I
SA	ME0000009071SFDAA00001	Qualatex Powder free Latex Examination Gloves Large	—
SA	ME0000009071SFDAA00002	Qualatex Powder free Latex Examination Gloves Medium	—

TAN SIN LIAN INDUSTRIES SDN BHD

Registrations by market

How these numbers were verified

Regulatory identity

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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